ASPIRIN

Adverse Events

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Aspirin Adverse Events Reported to the FDA Over Time

How are Aspirin adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Aspirin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Aspirin is flagged as the suspect drug causing the adverse event.

This graph shows the top adverse events submitted to the FDA for Aspirin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Aspirin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Aspirin

What are the most common Aspirin adverse events reported to the FDA?

Gastrointestinal Hemorrhages

5282 (5.5%)

Neurological

4500 (4.68%)

Gastrointestinal Signs

3651 (3.8%)

Respiratory

3375 (3.51%)

Hematology Investigations

3106 (3.23%)

Cardiac Arrhythmias

3038 (3.16%)

Central Nervous System Vascular

2539 (2.64%)

Gastrointestinal Ulceration And Per...

2459 (2.56%)

Medication Errors

2452 (2.55%)

Epidermal And Dermal Conditions

2426 (2.53%)

Suicidal And Self-injurious Behavio...

2425 (2.52%)

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Injuries

1921 (2%)

Anemias Nonhemolytic And Marrow Dep...

1672 (1.74%)

Chemical Injury And Poisoning

1672 (1.74%)

Cardiac And Vascular Investigations

1619 (1.69%)

Coronary Artery

1543 (1.61%)

Infections - Pathogen Unspecified

1530 (1.59%)

Hepatic And Hepatobiliary

1444 (1.5%)

Therapeutic And Nontherapeutic Effe...

1410 (1.47%)

Renal Disorders

1373 (1.43%)

Decreased And Nonspecific Blood Pre...

1331 (1.39%)

Vascular Hemorrhagic

1086 (1.13%)

Gastrointestinal Inflammatory Condi...

984 (1.02%)

Gastrointestinal Motility And Defec...

973 (1.01%)

Procedural And Device Related Injur...

973 (1.01%)

Lower Respiratory Tract Disorders

952 (.99%)

Psychiatric

844 (.88%)

Upper Respiratory Tract Disorders

838 (.87%)

Fatal Outcomes

831 (.87%)

Hepatobiliary

825 (.86%)

Muscle

798 (.83%)

Renal And Urinary Tract Investigati...

732 (.76%)

Electrolyte And Fluid Balance Condi...

719 (.75%)

Metabolic, Nutritional And Blood Ga...

715 (.74%)

Movement Disorders

678 (.71%)

Urinary Tract Signs

658 (.68%)

Allergic Conditions

655 (.68%)

Musculoskeletal And Connective Tiss...

652 (.68%)

Deliria

650 (.68%)

Physical Examination Topics

616 (.64%)

Anxiety Disorders

588 (.61%)

Angiedema And Urticaria

578 (.6%)

Heart Failures

541 (.56%)

Headaches

525 (.55%)

Platelet

499 (.52%)

Body Temperature Conditions

486 (.51%)

Seizures

483 (.5%)

Appetite And General Nutritional

455 (.47%)

Cardiac Disorder Signs

438 (.46%)

Vascular

433 (.45%)

Bronchial Disorders

432 (.45%)

Water, Electrolyte And Mineral

411 (.43%)

Embolism And Thrombosis

407 (.42%)

Joint

406 (.42%)

Skin Vascular Abnormalities

398 (.41%)

Bacterial Infectious

395 (.41%)

White Blood Cell

391 (.41%)

Glucose Metabolism Disorders

388 (.4%)

Enzyme

368 (.38%)

Skin Appendage Conditions

356 (.37%)

Oral Soft Tissue Conditions

355 (.37%)

Peritoneal And Retroperitoneal Cond...

351 (.37%)

Myocardial

347 (.36%)

Acid-base

344 (.36%)

Vision

344 (.36%)

Tissue

342 (.36%)

Vascular Hypertensive

342 (.36%)

Sleep Disorders

339 (.35%)

Lifestyle Issues

335 (.35%)

Coagulopathies And Bleeding Diathes...

315 (.33%)

Gastrointestinal Conditions

309 (.32%)

Toxicology And Therapeutic Drug Mon...

293 (.3%)

Hearing

285 (.3%)

Arteriosclerosis, Stenosis, Vascula...

278 (.29%)

Mental Impairment

270 (.28%)

Inner Ear And Viiith Cranial Nerve

251 (.26%)

Administration Site Reactions

245 (.26%)

Disturbances In Thinking

230 (.24%)

Pericardial

230 (.24%)

Ocular Neuromuscular

228 (.24%)

Eye

212 (.22%)

Therapeutic Procedures And Supporti...

200 (.21%)

Pleural

199 (.21%)

Bone And Joint Injuries

197 (.21%)

Diverticular

197 (.21%)

Depressed Mood Disorders

196 (.2%)

Increased Intracranial Pressure And...

193 (.2%)

Gastrointestinal Vascular Condition...

189 (.2%)

Gastrointestinal Neoplasms Malignan...

174 (.18%)

Ocular Hemorrhages And Vascular

170 (.18%)

Hematological And Lymphoid Tissue T...

167 (.17%)

Abdominal Hernias And Other Abdomin...

164 (.17%)

Neuromuscular

163 (.17%)

Viral Infectious

162 (.17%)

Product Quality Issues

161 (.17%)

Pulmonary Vascular

158 (.16%)

Cardiac Valve

146 (.15%)

Tongue Conditions

146 (.15%)

Dental And Gingival Conditions

143 (.15%)

Ocular Infections, Irritations And ...

143 (.15%)

Exocrine Pancreas Conditions

137 (.14%)

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This graph shows the top categories of adverse events submitted to the FDA for Aspirin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Aspirin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Aspirin According to Those Reporting Adverse Events

Why are people taking Aspirin, according to those reporting adverse events to the FDA?

Aspirin Case Reports

What Aspirin safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Aspirin. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.